Circle Rubber Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Circle Rubber Corp.” (first 1982, latest 1989), across 1 product code in 1 review panel. Median 510(k) review time under this name: 103 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 5 | 5 |
Review panels
Most recent Circle Rubber Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890407 | THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION | HIS | 1989-05-16 | 112 |
| K883467 | THE SAXON SPERMICIDAL CONDOM | HIS | 1988-10-26 | 75 |
| K872736 | PROPHYLACTIC (CONDOM) | HIS | 1987-10-20 | 103 |
| K842502 | WRINKLE CHAPEAU BLACKY | HIS | 1984-09-21 | 87 |
| K813172 | CONDOM-MULTIPAL STYLES | HIS | 1982-03-05 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Circle Rubber Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Circle Cardiovascular Imaging, Inc. (11 510(k)s)
- Circle Hearing Instruments, Inc. (1 510(k)s)
- Circle Neurovascular Imaging, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circle Rubber Corp.?
FDA lists 5 510(k) clearances under the applicant name “Circle Rubber Corp.” (first 1982, latest 1989), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Circle Rubber Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circle Rubber Corp. is 103 days.
Which FDA product codes appear under Circle Rubber Corp.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 5).
Next steps
- See all 5 Circle Rubber Corp. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Circle Rubber Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.